II. MEANING AND ELEMENTS

Appropriate criteria must be identified to define and classify an act of informed consent properly. If overdemanding criteria such as "full disclosure and complete understanding" are adopted, an informed consent becomes impossible to obtain. Conversely, if underdemanding criteria such as "the patient signed the form" are used, an informed consent becomes too easy to obtain and the term loses all moral significance. Many interactions between a physician and a patient or an investigator and a subject that have been called informed consents have been so labeled only because they rest on underdemanding criteria; they are inappropriately referred to as informed consents. For example, a physician's truthful disclosure to a patient has often been declared the essence of informed consent, as if a patient's silence following disclosure could constitute an informed consent. The existence of such inadequate understandings of informed consent can be explained in part by empirical information about physicians' beliefs about informed consent.

Contemporary Assumptions in Medicine

Data about the relevant beliefs of physicians in the United States were gathered in a 1982 survey of physicians conducted by Louis Harris and Associates. One question of this survey asked physicians, "What does the term informed consent mean to you?" In their answers, only 26 percent of physicians indicated that informed consent has something to do with a patient's giving permission, consenting, or agreeing to treatment. In a related question, only 9 percent indicated that it involves the patient's making a choice or stating a preference about his or her treatment (Harris and Associates; U.S. President's Commission, 1982). Similar results were found in a survey of Japanese physicians (Hattori et al.).

The majority of these physicians appear to regard disclosure as the primary (and perhaps sole) element of informed consent. That is, they conceive of informed consent as explaining to patients the nature of their medical conditions together with a recommended treatment plan. But if physicians regard informed consent as nothing more than an event of conveying information to patients, rather than a process of discussion with and obtaining permission from the patient, then claims that they regularly "obtain consents" from their patients before initiating medical procedures are both vague and unreliable.

Other polls conducted in the United States indicate that the majority of physicians understand an informed consent to be either a signed consent form or a disclosure. Some also conclude that no evidence exists that informed-consent practices are widespread in clinical medicine and that many agreements by patients that are called informed consents in some clinical settings fall far short of being meaningful informed consents (Lidz and Meisel).

The Elements of Informed Consent

Literature of bioethics often analyzes informed consent in terms of the following elements: (1) disclosure; (2) comprehension; (3) voluntariness; (4) competence; and (5) consent (see U.S. National Commission, 1978, U.S. President's Commission, 1982; Meisel and Roth, 1981). This analysis is sometimes joined with a corresponding thesis that these elements collectively define informed consent. The postulate is that a person gives an informed consent to an intervention if and only if the person receives a thorough disclosure about the procedure, comprehends the disclosed information, acts voluntarily, is competent to act, and consents.

This definition is attractive because of its consistency with standard usage of informed consent in medicine and law. However, medical convention and malpractice law have special orientations that tend to distort the meaning of informed consent in ways that need correction. Analyses that use the five elements listed above, as well as conventional usage in law and medicine, are best suited for cataloguing the analytical parts of informed consent and for delineating moral and legal requirements of informed consent, not for conceptually analyzing the meaning of informed consent. Neither requirements nor parts amounts to a definition.

The U.S. Supreme Court addressed the definition of informed consent in Planned Parenthood of Central Missouri v. Danforth as follows: "One might well wonder … what 'informed consent' of a patient is.… We are content to accept, as the meaning, the giving of information to the patient as to just what would be done and as to its consequences …" (Planned Parenthood of Central Missouri v. Danforth, 1976, p. 67). The essential element or part of informed consent, as described here, is disclosure, an analysis that recalls the assumptions made by physicians in the Harris poll (Harris and Associates). However, as we will see, nothing about an informed consent requires disclosure as part of its meaning, and this element does not amount to a definition. Moreover, to make disclosure the sole or even the major condition of informed consent incorporates questionable assumptions about medical authority, physician responsibility, and legal liability. These norms delineate an obligation to make disclosures so that a consent can be informed, rather than a meaning of informed consent. Even all five of the above elements merged as a set do not satisfactorily capture the meaning of informed consent.

Both the elements and the meaning of informed consent, then, need a more comprehensive treatment. The following seven categories express the analytical components of informed consent more adequately than the above five categories—although this sevenfold list does not adequately express the meaning of informed consent either (Beauchamp and Childress):

• Threshold elements (preconditions)
• Competence (to understand and decide)
• Voluntariness (in deciding)
• Information elements
• Disclosure (of material information)
• Recommendation (of a plan)
• Understanding (of terms 3 and 4)
• Consent elements
• Decision (in favor of a plan)
• Authorization (of the chosen plan)

The language of material information in (3) is pivotal for an adequate analysis of the elements of disclosure (3) and understanding (5). Critics of legal requirements of informed consent have often held that procedures sometimes have so many risks and benefits that they cannot be disclosed and explained in a reasonable period of time or in an understandable framework. The demands in this misreading of the nature and requirements of informed consent must be pruned, as many courts have pointed out. Material risks are the risks a reasonable patient needs to understand in order to decide among the alternatives; only these risks and benefits need to be disclosed and understood.

Corresponding to each of the above elements, one could construct informed-consent requirements. That is, there could be disclosure requirements, comprehension requirements, noninfluence requirements, competence requirements, authorization requirements, and so forth. These requirements would specify the conditions that must be satisfied for a consent to be valid.

Two Meanings of Informed Consent

Translating the above seven elements directly into a definition or meaning of informed consent invites confusion, because the term informed consent has subtleties not captured by these elements. A subtlety that has generated considerable misunderstanding is that two very different meanings of informed consent operate in current literature and social practices.

In the first meaning, an informed consent is an autonomous authorization of a medical intervention or of involvement in research by individual patients or subjects. An autonomous authorization requires more than merely acquiescing in, yielding to, or complying with an arrangement or a proposal made by a physician or investigator. A person gives an informed consent in this first sense if and only if the person, with substantial understanding and in substantial absence of control by others, intentionally authorizes a health professional to do something. A person who intentionally refuses to authorize an intervention but otherwise satisfies these conditions gives an informed refusal. This first sense derives from the philosophical premises that informed consent is fundamentally a matter of protecting and enabling autonomous or self-determining choice by patients and subjects and that final authority for making decisions about medical treatment or research participation properly rests with patients and subjects, not physicians or research scientists.

In the second meaning, informed consent is analyzed in terms of institutional and policy rules of consent. This sense expresses the mainstream conception in the regulatory rules of federal agencies and in healthcare institutions. Here informed consent refers only to a legally or institutionally effective approval by a patient or subject. An approval is therefore effective or valid if it conforms to the rules that govern specific institutions, whatever the operative rules may be. In this sense, unlike the first, conditions and requirements of informed consent are relative to a social and institutional context and need not be autonomous authorizations. This meaning is driven by demands in the legal and healthcare systems for a generally applicable and efficient consent mechanism by which responsibilities and violations can be readily and fairly assessed (Faden et al.).

Under these two contrasting understandings of informed consent, a patient or subject can give an informed consent in the first sense, but not in the second sense, and vice versa. For example, if the person consenting is a minor and therefore not of legal age, he or she cannot give an effective or valid consent under the prevailing institutional rules; a consent is invalid even if the minor gives the consent autonomously and responsibly. ("Mature minor" laws do sometimes make an exception and give minors the right to authorize medical treatments in a limited range of circumstances.)

The Relationship between the Two Meanings

Rules governing effective authorization have often not been premised on a carefully delineated conception of autonomous decision making, but current literature in bioethics suggests that any justifiable analysis of informed consent must be rooted in autonomous choice by patients and subjects. An act is increasingly recognized in this literature as an informed consent only if (1) a patient or subject agrees to an intervention based on an understanding of material information; (2) the agreement is not controlled by influences that engineer the outcome; and (3) an authorization for an intervention is given by the patient or subject with the understanding that it is an authorization.

In principle, although less clearly in practice, these conditions of informed consent (in the sense of an individual's autonomous authorization) can function as model standards for fashioning the institutional and policy requirements for effective consent. The model of autonomous choice would then serve as the benchmark against which the moral adequacy of prevailing rules and practices should be evaluated. The postulate that policies governing informed consent in the second sense should be formulated to conform to the standards of informed consent in the first sense is grounded in the premise that the primary goal of informed consent in medical care and in research is to enable potential subjects and patients to make autonomous decisions about whether to grant or refuse authorization for medical and research interventions (Katz).

It does not follow that institutional policies regarding informed consent are justifiable only if they rank the protection of decision making above all other values. Consent requirements imposed by institutions should be formulated and evaluated against a range of social and institutional considerations. The preservation of autonomous choice is the first but not the only consideration. For example, a patient's need for education and counseling in order to achieve a substantial understanding of a medical situation must be balanced against the interests of other patients and of society in maintaining a productive and efficient healthcare system. Accordingly, institutional policies must consider what is fair and reasonable to require of healthcare professionals and researchers and what the effect would be of alternative consent requirements on efficiency and effectiveness in the delivery of healthcare and the advancement of science.

tom l. beauchamp

ruth r. faden (1995)

bibliography revised

SEE ALSO: Autonomy; Competence; Information Disclosure, Ethical Issues of;Professional-Patient Relationship; and other Informed Consent subentries

BIBLIOGRAPHY

Appelbaum, Paul S.; Lidz, Charles W.; and Meisel, Alan. 1987. Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press.

Beauchamp, Tom L., and Childress, James F. 1994. Principles of Biomedical Ethics, 4th edition. New York: Oxford University Press.

Berg, Jessica W. 1996. "Legal and Ethical Complexities of Consent with Cognitively Impaired Research Subjects: Proposed Guidelines." Journal of Law, Medicine and Ethics 24(1): 18–35.

Berg, Jessica W.; Appelbaum, Paul S.; Parker, Lisa S.; Lidz, Charles W., eds. 2001. Informed Consent: Legal Theory and Clinical Practice. New York: Oxford University Press.

Biros, M. H.; Lewis, R. J.; Olson, C. M.; et al. 1995. "Informed Consent in Emergency Research. Consensus Statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers." Journal of the American Medical Association 273(16): 1283–1287.

Committee on Bioethics, American Academy of Pediatrics. 1995. "Informed Consent, Parental Permission, and Assent in Pediatric Practice." Pediatrics 95(2): 314–317.

Doyal, Len, and Tobias, Jeffrey S., eds. 2001. Informed Consent in Medical Research. London: BMJ Books. Faden, Ruth R.; Beauchamp, Tom L.; and King, Nancy M. P. 1986. A History and Theory of Informed Consent. New York: Oxford University Press.

Faden, Ruth. 1996. "Informed Consent and Clinical Research." Kennedy Institute of Ethics Journal 6(4): 356–359.

Gostin, Laurence O. 1995. "Informed Consent, Cultural Sensitivity, and Respect for Persons." Journal of the American Medical Association 274(10): 844–845.

Harris, Louis, and Associates. 1982. "Views of Informed Consent and Decisionmaking: Parallel Surveys of Physicians and the Public." In vol. 2 of Making Health Care Decisions, pp. 17–316. Washington, D.C.: U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

Hattori, Hiroyuki; Salzburg, Stephan M.; Kiang, Winston P.; Fujimiya, Tatsuga; Tejima, Yutaka; and Furuno, Junji. 1991. "The Patient's Right to Information in Japan—Legal Rules and Doctor's Opinions." Social Science and Medicine 32(9): 1007–1016.

Katz, Jay. 1984. The Silent World of Doctor and Patient. New York: Free Press.

Levine, Robert J. 1988. Ethics and Regulation of Clinical Research. 2nd edition. New Haven, CT: Yale University Press.

Lidz, Charles W., and Meisel, Alan. 1982. "Informed Consent and the Structure of Medical Care." In vol. 2 of Making Health Care Decisions, pp. 317–410. Washington, D.C.: U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

McConnell, Terrance C. 2000. Inalienable Rights: The Limits of Consent in Medicine and the Law. New York: Oxford University Press.

Meisel, Alan, and Roth, Loren H. 1981. "What We Do and Do Not Know About Informed Consent." Journal of the American Medical Association 246(21): 2473–2477.

Merz, Jon F., and Fischoff, Baruch. 1990. "Informed Consent Does Not Mean Rational Consent: Cognitive Limitations on Decision-Making." Journal of Legal Medicine 11(3): 321–350.

Planned Parenthood of Central Missouri v. Danforth. 423 U.S. 52 (1976).

Quill, Timothy E., and Brody, Howard. 1996. "Physician Recommendations and Patient Autonomy: Finding a Balance between Physician Power and Patient Choice." Annals of Internal Medicine 125(9): 763–769.

U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1978. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research. DHEW Publication (OS) 78–0012. Washington, D.C.: Department of Health, Education, and Welfare.

U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1982. Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. 3 vols. Washington, D.C.: Author.

Wear, Stephen. 1999. "Enhancing Clinician Provision of Informed Consent and Counseling: Some Pedagogical Strategies." Journal of Medicine and Philosophy 24(1): 34–42.

Wear, Stephen; Engelhardt, H. Tristam; and Wildes, Kevin W., eds. 1997. Informed Consent: Patient Autonomy and Clinician Beneficence Within Health Care (Clinical Medical Ethics Series). Washington, D.C.: Georgetown University Press.